The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a drug safety update on the increased risk of congenital malformations with fingolimod (Gilenya), with contraindication during pregnancy and in women of childbearing potential not using effective contraception.
The alert follows recent EU review of post-marketing data and concluded that fingolimod exposure in pregnancy is associated with a two-fold increase in the risk of congenital malformations compared with the observed rate of 2-3 per cent in the general population reported by the European network of population-based registries for the epidemiological surveillance of congenital anomalies (EUROCAT).
The MHRA is advising clinicians to exclude pregnancy before prescribing fingolimod and repeat pregnancy testing at suitable intervals during treatment. Health professionals are also advised to ensure that an effective form of contraception is used during treatment and for two months after discontinuation. Fingolimod should be stopped two months before a pregnancy is planned.
Should a woman on fingolimod become pregnant, treatment should be stopped immediately and the patient should be referred to an obstetrician for close monitoring.
At the time of licence of fingolimod in 2011, little clinical data were available about safety of use in pregnancy. The product information for fingolimod noted that animal data suggested a risk of foetal harm and therefore advised that women should not become pregnant while taking fingolimod. A registry was introduced to prospectively collect outcome data of any pregnancy exposed to fingolimod. Reported malformations include congenital heart disease, such as tetralogy of Fallot, atrial and ventricular septal defects and renal and musculoskeletal abnormalities.